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Rifaximin for Infection Prophylaxis in Hematopoietic Stem Cell Transplantation

NCT03529825 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2021-10-12

No results posted yet for this study

Summary

Primary purpose of the study is to see if rifaximin can improve the balance of bacteria within the gut, which has been shown to improve transplant outcomes. It will also assess whether rifaximin can reduce the risk of infection in blood/marrow transplant (BMT).

Conditions

  • Microbial Colonization

Interventions

DRUG

Rifaximin

Rifaximin will be administered twice a day orally or by nasogastric tube, at a dose of 15 mg/kg divided BID with a maximum dose of 1,650 mg, day -7 to day +28 or discharge (maximum duration 36 days).

Sponsors & Collaborators

  • Emory University

    lead OTHER

Principal Investigators

  • Muna Qayed, MD MSc · Emory University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-18
Primary Completion
2020-10-19
Completion
2021-09-10
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03529825 on ClinicalTrials.gov